Identity
- Trade Name
- Polysite FDA UDI
- Generic Name
- Vascular port/catheter FDA UDI
- Device Name
- POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes FDA UDI
- Model / Reference
- 2016SPI FDA UDI
- Description
- POLYSITE Pressure injectable Implantable Infusion Port with silicone-filled suture holes FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661234017546 FDA UDI
- 510(k) Number
- K122834 FDA UDI
- FDA Product Code
- LJT FDA UDI
- GMDN Term
- Vascular port/catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5965 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Vascular port/catheter
Polysite by Perouse Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular port/catheter.
- Deltec — ICU MEDICAL, INC. · Class II
- PowerPort M.R.I., ChronoFlex — Bard Access Systems, Inc. · Class II
- PowerPort M.R.I., ChronoFlex — Bard Access Systems, Inc. · Class II
- PowerPort M.R.I. — Bard Access Systems, Inc. · Class II
- Vital-Port — COOK INCORPORATED · Class II
- Vortex — NAVILYST MEDICAL, INC. · Class II
- PowerPort — Bard Access Systems, Inc. · Class II
- Deltec — ICU MEDICAL, INC. · Class II
Cleared under the same submission
K122834 also covers:
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- Polysite — PEROUSE MEDICAL
- ARROW — TELEFLEX INCORPORATED
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Perouse Medical
Sources (1)
- FDA UDI 6e059b1a-f9b8-4c58-9c28-8eceac36fb93 34 fields · synced May 30, 2026